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目的:考察银杏达莫分散片的制剂质量。方法:采用高效液相色谱法对分散片中双嘧达莫进行含量测定,并参照中国药典对分散片质量要求进行评价。结果:双嘧达莫在20～400μg(r=0.9992)内与峰面积呈良好的线性关系,平均回收率为99.9%(RSD=1.73%,n=9)。3批样品的平均含量分别为99.6%,94.6%,95.2%。分散片外观、片重差异、硬度测定、分散均匀度、体外溶出度均符合标准要求。结论:银杏达莫分散片的制剂工艺处方设计合理,银杏达莫分散片分散均匀度及体外溶出度性能良好。
Objective: To investigate the preparation quality of ginkgo damo dispersible tablets. Methods: The content of dipyridamole in dispersible tablets was determined by HPLC, and the quality requirements of dispersible tablets were evaluated with reference to the Chinese Pharmacopoeia. Results: The dipyridamole showed a good linear relationship with the peak area in the range of 20-400μg (r = 0.9992). The average recovery was 99.9% (RSD = 1.73%, n = 9). The average contents of three batches of samples were 99.6%, 94.6% and 95.2% respectively. Dispersing tablets appearance, weight differences, hardness determination, dispersion uniformity, in vitro dissolution are in line with standard requirements. Conclusion: The prescription of preparation of Yinxingdamo dispersible tablet is reasonable. The dispersion uniformity and in vitro dissolution of Yinxingdamo dispersible tablets are good.